NEPHRO-URETERAL STENT— 510(k) K942688

Substantially Equivalent

Uresil Corp.

FDA 510(k) clearance K942688 for NEPHRO-URETERAL STENT, Substantially Equivalent on 1995-06-06. Applicant: Uresil Corp.. Device class: Unclassified.

Clearance details

Applicant
Uresil Corp.
Product code
Code LJE
Device class
Unclassified
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Skokie, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LJE

product code LJE
Death
6
Total
6

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.